Glaxo To File Experimental Diabetes Drug Albiglutide In Early 2013

By Sten Stovall

LONDON--GlaxoSmithKline PLC (GSK) aims to file its experimental once-weekly diabetes drug albiglutide for regulatory approval early next year following the read-out from a series of clinical trials.

The British company said Wednesday that top-line data from eight late-stage Phase III clinical studies had now been received and, when taken together, support advancing albiglutide to regulatory submission.

Albiglutide is an investigational biological form of human GLP-1 and isn't currently approved anywhere in the world. Human Genome Sciences (HGSI) discovered albiglutide and licensed it to Glaxo for late-stage testing. The drug is a form of GLP-1--a human protein that helps the body maintain normal blood-sugar levels.

Glaxo's regulatory filings for albiglutide will be based on a Phase III clinical development program comprising eight individual studies, known as Harmony 1 to Harmony 8, involving some 5,000 patients. The program is investigating the efficacy, tolerability and safety, including cardiovascular safety, of albiglutide as mono- and add-on therapy, in patients with Type 2 diabetes.

The latest read out came from Harmony 8, a 52-week study comparing albiglutide with Januvia, made by Merck & Co (MRK).

Glaxo said Harmony 8 "is the first completed study of a GLP-1 agonist to assess efficacy and safety across the spectrum of renal impairment from mild to severe, and the third of eight Harmony Phase III studies to complete." It said albiglutide was generally well-tolerated.

Results from the eight studies rule out excess cardiovascular risk, according to a threshold prespecified by the U.S. Food and Drug Administration.

"Analyses of the data support progression to submission and will be presented to health authorities in the coming months," the company said.

Shares in Glaxo closed up 0.8% at 1,465 pence.

-Write to Sten Stovall at [e-mail]